Kornimate/medical-research-clean huggingface dataset:
study to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of liposomal sirna in subjects with high cholesterol

Conditions: Hypercholesterolemia

Summary: this study is a phase 1, single-center, placebo-controlled, single-blind, first-in-human, single-ascending dose study in male and female subjects with high cholesterol. a maximum of 32 subjects is planned for enrollment in this study.


Eligibility criteria:
inclusion criteria: * fasting, stable ldl-c ≥ 160 mg/dl * fasting, stable triglyceride \< 400 mg/dl * bmi between 22 and 35 kg/m2, inclusive * females must be of non-child bearing potential * males of reproductive potential must agree to practice effective contraception throughout the study and for 3 months following infusion exclusion criteria: * clinically significant endocrine, hematologic, renal, hepatic, pulmonary, uncontrolled psychiatric, or neurologic disease * cancer within 5 years prior to screening * history of congestive heart failure or chronic heart failure * uncontrolled cardiac arrhythmias * history of coronary heart disease * clinically significant abnormal baseline ecg * history of additional risk factors for torsades de pointes * hepatitis b, c, or hiv positive * current diagnosis or known history of liver disease * a marked baseline prolongation of qt/qtc interval * known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained muscle pain, or a creatine phosphokinase (cpk) \>3 x upper limit of normal (uln) at screening * alanine aminotransferase, ast, ggt, or total bilirubin \>2 x uln at screening * serum creatinine \> 1.5 mg/dl * systolic blood pressure ≥ 160 mmhg or diastolic blood pressure ≥ 100 mmhg on 2 occasions during screening * concomitant use of medications that prolongs the qt/qtc interval * treatment with lipid lowering therapy within 30 days prior to screening * use of investigational drug within 3 months prior to screening

Keywords: cholesterol coronary artery disease
study to evaluate whether a medication event monitoring system (mems) can improve adherence to tecfidera treatment in multiple sclerosis patients.

Conditions: Multiple Sclerosis

Summary: the primary objective of the study is to determine whether a medication event monitoring system (mems®) cap with a liquid crystal display (lcd) reader (a "smart" cap) along with additional patient counseling intervention (arm 3) can improve adherence to dimethyl fumarate (dmf) treatment in multiple sclerosis (ms) patients as compared to a mems cap without an lcd reader (a "standard" cap) and no patient counseling intervention (standard of care, arm 1) at month 12. the secondary objectives of this study in this study population are: to determine if data display on a smart mems cap with an lcd reader (arm 2) can improve adherence as compared to a standard mems cap without an lcd reader (arm 1) at month 12; to determine whether the addition of patient counseling intervention based on mems data (arm 3), or data display from a mems cap with an lcd reader (arm 2) can improve adherence compared to standard mems cap without an lcd reader (arm 1) at month 6; to assess persistence and compliance at months 6 and 12 for all arms; to assess the association between adherence and patient- reported outcomes (pros) for all arms including multiple sclerosis impact scale (msis-29), and the work productivity and activity impairment questionnaire (wpai): ms v2.0.


Eligibility criteria:
key inclusion criteria: * the candidate is a dmf-naïve patient * have a diagnosis of relapsing forms of ms and satisfy the approved therapeutic indication for dmf * have a recent (i.e., within the previous 6 months) complete blood count with results that do not preclude the patient's participation in the study, in the judgment of the investigator key exclusion criteria: * have comorbid conditions that preclude participation in the study, as determined by the investigator * history of severe allergic or anaphylactic reactions or known drug hypersensitivity * are participating, planning to participate, or have participated in the tecfidera quickstart program note: other protocol defined inclusion/exclusion criteria may apply
computer modelling of the cervical spine movements in cervical dystonia

Conditions: Cervical Dystonia, Primary

Summary: cervical dystonia (cd) is a syndrome characterized by sustained and/or phasic involuntary neck muscle activity causing abnormal head postures and movements. it is the most frequent form of adult focal dystonia. the distribution of dystonic muscles is unique for each patient, explaining the variety of patterns encountered. the therapeutic management of cd is essentially local and symptomatic: botulinum neurotoxin injections and/or specific retraining therapy programmes. therefore, analyzing the characteristics of abnormal head movements and identifying the dystonic muscles are the key points of these treatments. to a better understanding of the posture and movement disorders of head and neck, we wish to establish a three-dimensional (3-d) computer model of cervical spine movements of ten healthy subjects built from images obtained with the "cone beam " system. then we will compare the cervical posture and movements for each of ten cd patients matched in age and genre to the computer model. comparison with patients' images in the axial plane reconstructed by computer with the 3-d computer model will lead to the description of various patterns of cd. analysis of the musculoskeletal disturbances in cd should be a help to improve the localization of botulinum neurotoxin injection sites as well as retraining programmes.


Eligibility criteria:
inclusion criteria: * tonic form of focal or segmental cervical dystonia (diagnostic confirmed by a neurologist specialized in movement disorders) for cd patients, or absence of cd for control subjects * absence of treatment by botulinum neurotoxin, or last injection \> 3 months * age \> 18 and \< 71 years * informed consent * medical insurance coverage exclusion criteria: * cd mobile (clonic) and/or head tremor * patient unable to sit without moving the head during the examination (x-ray pictures with cone beam) * other neurological disease with effect on the posture and/or movement of the cervical region * pain or traumatism of the cervical region requiring medical or surgical treatment in the preceding 6 months * pregnant or breast feeding patient * participation in another research with a potential impact on evaluation criteria * patient under judiciary protection

Keywords: cervical spine musculoskeletal imagery computer modelling of cervical spine conebeam.
anosmia and covid-19

Conditions: Anosmia; SARS CoV 2 Infection

Summary: our study aims to determine the prevalence of anosmia in patients sars-cov-2/covid-19 infection (both by symptom reporting and smell testing), the efficacy of early olfactory training for the treatment of anosmia caused by infection and the long-term impact of smell dysfunction with a one-year follow-up.

around 10-15% of patients with acquired anosmia have post viral olfactory loss (pvol). coronaviruses are a known cause for anosmia. at the onset of the covid-19 pandemic, reports from china, south korea, us and europe suggest that a significant proportion of covid-19 patients describe a loss of smell and taste as the only symptoms or as part of mild flu-like symptoms. it is now well-established that these symptoms are important components of the covid-19 sequelae with persistent dysfunction described in a subset of individuals. for this study, individuals, mainly comprising mainly healthcare workers in the uk, with persistent and sudden loss of sense of smell (at least 4 weeks) were recruited to ascertain the prevalence of covid-19 associated smell dysfunction. a positive covid-19 test was not a requirement for participation if not readily available nor accessible, however, information regarding covid-19 antigen and antibody testing was collected post-hoc from those for who data are readily available. all participants (n=227) underwent initial psychophysical smell testing using the brief smell identification test (bsit), gustatory testing using taste strips and completed the smell qx questionnaire. this questionnaire collected relevant demographic information, medical history, details of covid-19 symptoms experienced, as well as information on olfactory and gustatory function, including those related to quality-of-life. participants, who scored 8 or below on the bsit (indicative of semi-quantitative smell loss) were further invited to participate in the early olfactory training randomized controlled trial. participants were randomized to undergo either 12 weeks of olfactory training or receive safety information. at the end of the 12-weeks, participants completed a follow-up bsit and survey. all participants enrolled at baseline within the eligible timeframe, for whom a valid email address was available, were further invited to participate in 1 year follow-up assessments. this included all participants irrespective of baseline bsit result and rct participation. the follow-up included a final electronic survey and bsit. in addition to questions related to their sense of smell, which were identical to those in the baseline and 12-week follow-up surveys, participants were also asked about any symptoms of long-covid.

Eligibility criteria:
inclusion criteria: * confirmed (positive laboratory antigen test) or suspected covid-19 infection * sudden onset of smell loss * smell loss of at least 4 weeks * reduced smell function through psycho-physical testing (brief smell identification test score of 8 or less) exclusion criteria: -
multimodal mri in multiple sclerosis (ms): reliability and follow up

Conditions: Multiple Sclerosis

Summary: to determine wether multimodal mri (conventinal t1 and t2 sequences, diffusion, magnetization transfer, spectroscopy) is reproducible; to follow up a cohort of patients with early remmittent ms after treatment with interferon.


Eligibility criteria:
inclusion criteria: * ms patients according to poser's criteria * remitting evolution (less than two years of evolution) * aged 18-50 * immunomodulatory treatment indicated exclusion criteria: * unable to perform mri

Keywords: aged 18-50 remitting evolution less than two years of evolution ms patients
measurement of cardiac output and intravascular volume status in children using costatus (sh)

Conditions: Intensive Care

Summary: assessment and monitoring of cardiac function in the pediatric intensive care unit (picu) is an integral part of hemodynamic monitoring of critically ill patients whether it is done directly or indirectly. measurement of cardiac output (co) can specifically guide therapies to support the cardiovascular system in critically ill children with multi organ dysfunction. because of the side effects involved in measuring cardiac output directly, intensive monitoring of patients is currently limited to an integrated assessment of tissue perfusion, oxygen delivery and cellular health both at regional and global levels. currently available methods of measuring co have their limitations and complications, and are not used routinely for bedside monitoring. therefore, the investigators propose to use a newly developed method, termed costatus for the monitoring of co in patients admitted to picu.


Eligibility criteria:
inclusion criteria: 1. patients under 21 years 2. presence of compensated or decompensated shock irrespective of etiology 3. presence of an existing peripheral arterial and central venous catheters exclusion criteria: 1. patients allergic to heparin
nicotine pharmacokinetic study of heated tobacco and heated herbal products

Conditions: Healthy Volunteers

Summary: this is a randomised, cross-over, open-label, confinement study conducted in 25 adult male or female smokers of combustible cigarettes (ccs). the study investigates combustible cigarettes, heated tobacco products (htps), and heated herbal products (hhps), with endpoints including pharmacokinetic evaluation, and subjective effects. subjects will perform a screening visit and one study visit, including a 6-day confinement period.


Eligibility criteria:
inclusion criteria: * reports smoking an average of at least 10 manufactured combustible (menthol or non-menthol) cigarettes per day for at least 12 months prior to screening * has a positive urine cotinine (\>500 ng/ml) at screening * has an exhaled carbon monoxide \>10 ppm at screening * female subjects of childbearing potential must use contraception * male subjects must use contraception exclusion criteria: * has a history or presence of clinically significant disease or condition that, in the opinion of the investigator, would jeopardise the safety of the subject or impact the validity of the study results. * has a positive test for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c virus (hcv) at screening * has a body mass index (bmi) \> 30.0 kg/m\^2 or \< 18.0 kg/m\^2 at screening * has a fever (\>38.05°c) at screening or check-in * has a history or presence of drug or alcohol abuse within 24 months of check-in * pregnant or lactating females * has used any prescription smoking cessation treatments within 3 months prior to check-in is planning to quit smoking during the study or within the next 3 months
assessing function and pain after total knee arthroplasty with combined femoral and popliteal nerve block

Conditions: Total Knee Arthroplasty; Total Knee Replacement; Total Knee Replacement Surgery; Arthritis Knee; Rehabilitation

Summary: the goal of this interventional study is to examine whether a pain management technique of combined femoral and popliteal nerve block is effective in total knee arthroplasty patients. the main questions it aims to answer are: are there differences in postoperative outcomes? does the nerve block, age, preoperative quadriceps muscle strength and oxford knee score of the patient predict early functional ability? participants underwent total knee arthroplasty and assessments. researchers compared pain management techniques to assess effects on postoperative outcomes and identified the importance of preoperative variables a predictors of early functional ability. further research is required to refine postoperative pain management strategies.


Eligibility criteria:
inclusion criteria: * over the age of 18 * electively assigned for primary knee replacement surgery. * the american society of anesthesiologists physical status score 1-3. exclusion criteria: * revision surgery. * patients suffering from chronic pain syndrome or chronic opioid use. * patients with previous neurological deficits in the lower extremities. * a cognitive state that does not allow signing of consent or understanding simple instructions.
combination of irreversible electroporation and nk immunotherapy for advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of the combined therapy using irreversible electroporation（ire）and nature killer(nk) cells for advanced pancreatic cancer.

by enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using irreversible electroporation（ire）and nature killer（nk） cells for advanced pancreatic cancer. the efficacy will be evaluated according to relief degree,progress free survival(pfs) and overall survival(os). the safety will be evaluated by statistics of adverse reaction

Eligibility criteria:
inclusion criteria: 1. age:18-80 2. diagnosis：advanced and active pancreatic cancer 3. the tumour is measurable 4. eastern cooperative oncology group(ecog) score：0\~2；3 but has no relationship with tumour 5. vital organ function is normal: total bilirubin(tb) \ 80×10\^9/l red blood cell specific volume(hct)\>0.20 non severe viral or bacterial infection 6. non pregnant and lactating patients 7. non allergic reactions to biological products 8. informed and consent exclusion criteria: 1. patients with cardiac pacemaker 2. patients with severe cardiac and pulmonary dysfunction 3. patients that the researchers do not think fit into the group,including patients failed in compliance assessment

Keywords: advanced pancreatic cancer nature killer cell irreversible electroporation
evaluation of sublingual microcirculation in burn during resuscitation

Conditions: Burn Shock

Summary: the adequacy of fluid resuscitation will be monitored in burn patients using microcirculation. microcirculation camera will be placed on the base of the tongue and at different four quadrants. • microcirculation parameters at baseline and after 8h , 16h and 24h of fluid resuscitation will be recorded. fluid resuscitation with lactated ringer according to parkland formula (4 ml/kg/%tbsa) 50% given during the first 8 hours, with the remainder given during the following 16 hours, will be initiated to maintain a urinary output of 0.5ml/kg/hr.norepinephrine infusion will be started in case of circulatory failure at a rate of 0.02mic/kg/min to maintain map of 65-70mmhg.


Eligibility criteria:
inclusion criteria: * age more than 18 years old * burn \>20% tbsa * patients with burn admitted within the 1st 6 hours exclusion criteria: * age \< 18 years old. * pregnant patients. * patients with severe renal insufficiency. * patients shocked due to other causes as sepsis, hypovolaemia or cardiogenic shock * patients with airway edema that preclude the measurement of sublingual microcirculation
efficacy of gelatin tannate in treatment acute gastroenteritis in children.

Conditions: Acute Gastroenteritis

Summary: gelatin tannate possesses astringent, antibacterial, and anti-inflammatory properties. it is increasingly being marketed as an antidiarrheal drug. a randomized, double blind, placebo-control trial was performed to assess the effectiveness of gt in management of children with acute gastroenteritis.


Eligibility criteria:
inclusion criteria: * children \< 5 years old * diarrhea (defined as the passage of 3 or more loose or watery stools per day) for \> 1 day but \< 5 days * inform consent sign exclusion criteria: * regularly used antibiotics, probiotics, gelatin tannate, diosmectite, racecadotril within 7 days before admission * underlying gastrointestinal tract disorder presenting with diarrhea * breastfeeding \>50% * malnutrition (weight/high \<3pc)

Keywords: diarrhea, gelatin tannate, acute gastroenteritis
intravitreal bevacizumab and triamcinolone in diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: one of the most frequent complications of diabetic retinopathy is diabetic macular edema. recently, intravitreal bevacizumab and intravitreal triamcinolone were the most popular therapeutic modalities. however, as the long term effects of intravitreal bevacizumab and intravitreal triamcinolone on visual acuity and macular thickness have not been compared, it was the purpose of the present study to compare these treatment effects

randomization of intravitreal bevacizumab, intravitreal triamcinolone, intravitreal bevacizumab with triamcinolone on eyes with diabetic macular edema

Eligibility criteria:
inclusion criteria: * diabetic macular edema (central macular thickness greater than 300 mm on optical coherence tomography ) exclusion criteria: * history of glaucoma or ocular hypertension (defined as an intraocular pressure higher than 22 mmhg) * an ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study (e.g. retinal vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, irvine-gass syndrome, etc.) * systemic corticosteroid therapy history of thromboembolic event (including myocardial infarction or cerebral vascular accident) * major surgery within the prior 6 months or planned within the next 28 days

Keywords: bevacizumab, diabetic macular edema, triamcinolone
effects of upper extremity rehabilitation using smart glove in stroke patients

Conditions: Stroke; Hemiplegia

Summary: the purpose of this study is to evaluate the therapeutic effects of smart glove which is motion-based program designed for upper extremity rehabilitation after stroke.

this study will evaluate the therapeutic effects (upper extremity power, function and activity of daily living) of smart glove which is motion-based rehabilitation program.

Eligibility criteria:
inclusion criteria: * ct or mri proved 1st stroke patients with unilateral hemiplegia caused by stroke (ischemic, hemorrhagic, intracranial hemorrhage) * 72 hours \~ 3 months after stroke * upper extremity hemiplegia with brunnström stage 2-5. * the patients can sit to receive treatment for at least 1 hour exclusion criteria: * the patients cannot perform occupational treatments because of severe hemineglect or hemianopia * contracture due to severe limitation of motion * upper extremity spasticity in the wrist and fingers with modified ashworth scale \> 2 points * fugl-meyer assessment-wrist \& hand score \>= 21 points * moderate to severe cognitive dysfunction \< mmse 18 points * severe aphasia * the patients who has been diagnosed as malignant tumor
a comparison of three nebulizers for standard clinical and research use in methacholine challenge testing

Conditions: Asthma

Summary: the study will assess three different nebulizers for use in methacholine challenge testing in order to determine if the aeroneb solo would make a suitable replacement for the long-used and now obsolete wright and bennett-twin nebulizers. results from each device will be compared to evaluate whether current guidelines for the methacholine challenge should be updated for superior standardization.

sixty asthmatics (20 at each testing site: university of saskatchewan, mcmaster university, laval university) will be recruited to undergo this randomized, triple cross-over study. three nebulizers will be tested, the wright, the bennett-twin and the new aeroneb solo. breakdown of study procedure: participants will undergo three (potentially four) methacholine challenges, one with each nebulizer in randomized order. an additional methacholine challenge may be performed for screening purposes if the participant has not undergone methacholine challenge testing in one of the participating labs in the previous 6 months. the screening challenge will be performed with the standard nebulizer used at the given testing site (i.e. the wright or the bennett-twin). the methacholine challenges performed with the wright and bennett-twin nebulizers will follow the two-minute tidal breathing protocol as outlined in the 1999 american thoracic society guidelines for methacholine challenge testing. the testing protocol used with the aeroneb solo will be identical save for a 1 min inhalation period instead of 2 min. each challenge will be stopped when a participant's forced expiratory volume in 1 second (fev1) drops at least 20%. this will allow for the determination of the participant's pc20 (provocative concentration of methacholine causing a 20% fall in fev1), which will subsequently be converted to a pd20 (provocative dose) value. a minimum 24-hour washout period between challenges will be enforced.

Eligibility criteria:
inclusion criteria: * men and women aged 18 or older * stable asthma * baseline methacholine pc20 less than or equal to 16mg/ml * baseline lung function greater than 65% predicted exclusion criteria: * use of long-acting bronchodilators within 30 days of visit 1 * pregnant or nursing * cardiovascular problems * respiratory illness within 4 weeks of visit 1 * allergen-induced asthma exacerbation within 4 weeks of visit 1